The FDA and the European Medicines Agency (EMA) announced the availability of the “EMA–FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications,” which supports quality development for FDA’s Breakthrough Therapy (BT) designation and EMA’s Priority Medicines (PRIME) scheme programs for patients with unmet medical needs.
These Q&As are a direct result of a 2018 workshop held by both FDA and EMA where regulators and industry discussed quality challenges and scientific and regulatory approaches for facilitating development and preparation of pharmaceutical quality data packages. These conversations focused on enabling timely access to medicines for patients while keeping in mind the importance of drug safety, efficacy, and quality and maintaining current regulatory standards of approval. FDA and EMA have discussed these topics further, sharing their experiences and regulatory expectations in the context of PRIME/BT applications and which are outlined in the document.
The document contains four Q&A sections that compile FDA and EMA’s current thinking on the following topics:
- Annex 1. Q&A on control strategy considerations for PRIME/BT applications
- Annex 2. Q&A on process validation approaches for PRIME/BT applications
- Annex 3. Q&A on alternatives for determination of re-test period or shelf-life for PRIME/BT applications
- Annex 4. Q&A on GMP considerations for PRIME/BT applications
Visit FDA’s International Regulatory Harmonization page for more information about the ongoing discussions between FDA and EMA.
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